National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Evaluating the efficiency of bacterial bioactive peptides as antifungal and antimycotoxin agents for food preservation

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

- The title does not agree with either the purpose of the study or with those written in the procedures. Therefore, it is suggested to change the title to

 Evaluating the efficiency of bacterial bioactive peptides on reduction the carcinogenic effect for mycotoxins in rats and human cell line

تقييم كفاءة الببتيدات البكتيرية النشطة حيوياً فى تقليل التأثير المسرطن للسموم الفطرية فى الفئران وخلايا الانسان معمليا

- Role/tasks for PI: Written what has been done. This is not its place here.

- Study Type: Written Human, Tissues. While, the study on Animals and on Biospecimens (cell line).

- Anticipated Start Date: Written The work will start after completion of all necessary approvals. While, Commitment form Signatured in 21-6-2023. How, The proposal is presented in 30-9-2025.

- Duration of the study: Written 3 years. While, in Role/tasks of PI Written 4.6 years.

- Keywords: Delete probiotic. And Added human cell line, rats.

- Research Team: written one Co-Investigator only. While, The proposal is Ph. D. Thesis

and there are three other supervisors. The rest of the supervisors need to be added.

- Procedure: Step 1: Preparation of supernatant and inoculum for Lactobacillus spp and Bacillus spp: Didn't he write the source of the bacteria; is will it isolate or buy. And if it is to be isolate, the steps of the isolate have not been written.

- Procedure: Step 2: Studying the ability of identified bioactive peptides to reduce the harmful effects of mycotoxins: The type of mycotoxin and the dose to be used has not been specified, and also, dose of Bioactive peptides, whether the high dose or the low dose.   

- It is written that she will take blood and tissue samples from the mice. The blood sample size was not recorded nor what would be measured (blood parameters).

- The type of tissue to be taken has not been specified. And what tests will be conducted on it.

- Procedure: Step 3: Evaluation of cytotoxicity of bioactive peptides: The source of Human cell line (normal and carcinogenic) was not written. The cancer drug that will be used has not been prescribe Written ed. Also, the dosage in the treatment was not written.

- Gantt Charts: Written 3 years. While, in Role/tasks of PI Written 4.6 years.

- References: Not right: Liu et al., 2019 not found in References list. Reference de Ullivarri et al., 2020 repeated again in another writing (Fernández de Ullivarri et al., 2020).

- Application for Clinical Research Studies Involving Humans: Origin of biospecimen, Microbiology. Required, replacement of the human by Biospecimens.

 - Mention the source of identifiable biospecimen: The source of human cell line was not written, just written Biobank.

- Are biospecimens to be used for commercial purposes: Written Yes. How?

- What is the expected duration of storage of biospecimens: Written up to 14 years or more at ultra-low temperatures. How?

- Commitment form: Signatured in 21-6-2023. Has the work been done?

- Conflict of interest: Attached is the researcher's declaration regarding animal care. How?. And the image is unclear.

- Department and institutional approval: Form 90 does not exist. But a part of the supervision form exists. And all Signatures (Department, Scientific Committee, and Division) in 6-2023. How?.  

Comment to the Committee

Informed consent form:

Waiver

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